1] Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan [2] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Department of Gastroenterology, Hokkaido University Hospital, Hokkaido, Japan.
Br J Cancer. 2014 Jan 21;110(2):271-7. doi: 10.1038/bjc.2013.726. Epub 2013 Nov 26.
This randomised phase II trial compared dose-escalated weekly paclitaxel (wPTX) vs standard-dose wPTX for patients with previously treated advanced gastric cancer (AGC).
Ninety patients were randomised to a standard dose of wPTX (80 mg m(-2)) or an escalated dose of wPTX (80-120 mg m(-2)) to assess the superiority of overall survival (OS) with a one-sided alpha error of 0.3 and a power of 0.8.
The median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs 9.6 months; hazard ratio (HR), 0.75; one-sided P=0.12), although it was statistically not significant. The median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs 2.5 months, HR, 0.55; P=0.017). Objective response rate was 30.3% with dose escalation and 17.1% with standard dose (P=0.2). The frequency of all grades of neutropenia was significantly higher with dose escalation (88.7% vs 60.0%, P=0.002); however, no significant difference was observed in the proportion of patients experiencing grade 3 or more (40.9% vs 31.1%, P=0.34).
Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point, OS (P<0.3); however, it did not show a significantly longer OS. Progression-free survival was significantly better with dose escalation.
这项随机 2 期临床试验比较了剂量递增的每周紫杉醇（wPTX）与标准剂量 wPTX 治疗既往治疗过的晚期胃癌（AGC）患者的疗效。
90 例患者被随机分为标准剂量 wPTX（80mg/m2）或递增剂量 wPTX（80-120mg/m2）组，以单侧 alpha 误差为 0.3 和功效为 0.8 来评估总生存期（OS）的优势。
递增剂量组的中位 OS 显示出更长的生存趋势（11.8 个月 vs 9.6 个月；风险比（HR），0.75；单侧 P=0.12），尽管统计学上无显著性差异。递增剂量组的中位无进展生存期（PFS）明显更长（4.3 个月 vs 2.5 个月，HR，0.55；P=0.017）。递增剂量组的客观缓解率为 30.3%，标准剂量组为 17.1%（P=0.2）。递增剂量组的所有级别中性粒细胞减少症的发生率明显更高（88.7% vs 60.0%，P=0.002）；然而，在发生 3 级或更高级别的患者比例方面没有观察到显著差异（40.9% vs 31.1%，P=0.34）。
在既往治疗过的 AGC 患者中，递增剂量的 wPTX 达到了我们预先设定的主要终点 OS（P<0.3）的阈值；然而，它并没有显示出明显更长的 OS。递增剂量组的无进展生存期明显更好。
